Intrauterine Balloon Tamponade Research Articles

Cross-Sectional Survey to Assess Hospital System Readiness for Hemorrhage During and After Cesarean Delivery in Africa.

Mothers in Africa are 50 times more likely to die after cesarean delivery (CD) than in high-income countries, largely due to hemorrhage. It is unclear whether countries across Africa are adequately equipped to prevent and treat postpartum hemorrhage (PPH) during and after CD. This was a cross-sectional survey of anesthesiologists and obstetricians across the African Perioperative Research Group (APORG). The primary objective was to determine readiness of the hospital system to implement the World Health Organization (WHO) recommendations for prevention and treatment of PPH during and after CD. The secondary objectives were to evaluate the availability of blood products, skilled human resources and establish available postoperative care after CD. Survey question format was close-ended or Likert scale, with options "always," "sometimes," or "never." Responses were analyzed from 1 respondent from each of 140 hospitals from 29 low- and middle-income countries across Africa. Most respondents completed every data field on the case report form. Regarding WHO recommendations on prevention of PPH, oxytocin and misoprostol were available in 130/139 (93.5%) and 101/138 (73.2%) hospitals, respectively. There was limited access to heat-stable carbetocin (12/138 [8.7%]) and ergometrine (35/135, [25.9%]). Controlled cord traction for removal of placenta was always performed in 133/135 (98.5%) hospitals. Delayed cord clamping when neonatal resuscitation was not indicated, was not performed universally (86/134 [64.2%]). Regarding the treatment of PPH, crystalloids were always available in 133/139 (95.7%) hospitals, and the preferred initial resuscitation fluid (125/138 [90.6%]). Uterine massage was always performed in 117/139 (84.2%) hospitals. Tranexamic acid was always available in 97/139 (69.8%) hospitals. The availability of intrauterine balloon tamponade devices was limited. Most had immediate access to theater (126/139 [90.6%]). Responses concerning organizational recommendations showed that 113/136 (83.1%) hospitals had written protocols for the treatment of PPH. Protocols for patient referral and simulation training were limited. Most hospitals had access to emergency blood (102/139 [73.4%]). There was limited access to blood component therapy, with platelets available at 32/138 (23.2%), cryoprecipitate at 21/138 (15.2%) and fibrinogen at 11/139 (7.9%) hospitals. In-person specialist cover was reduced after-hours. Important WHO-recommended measures to reduce hemorrhage during and after CD, are not currently available in many hospitals across Africa. It is likely that the lack of a combination of factors leads to failure to rescue mothers in Africa from postoperative complications. These findings should facilitate codesign of quality improvement initiatives to reduce hemorrhage related to CD.

Efficacy of Intrauterine Condom Balloon in the Treatment of Atonic Postpartum Hemorrhage

Introduction: Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality, particularly in cases of uterine atony. Effective management is crucial to prevent severe complications and improve maternal outcomes. Intrauterine balloon tamponade techniques, such as the use of a condom balloon tamponade (CBT), have gained attention for their potential to control bleeding quickly and safely. This study aimed to assess the efficacy of intrauterine condom balloons in the treatment of atonic postpartum hemorrhage. Methods: This study is a prospective observational study conducted to assess the efficacy of intrauterine condom balloon tamponade (CBT) in the management of atonic postpartum hemorrhage (PPH). The study was carried out at the Department of Obstetrics and Gynecology in Dhaka Medical College Hospital, from January 2007 to December 2007. A total of 50 patients were selected by a purposive sampling technique. All collected data were analyzed using SPSS software (version 25.0). For continuous variables (e.g., blood loss, time to hemostasis), comparisons between groups (e.g., successful vs. unsuccessful tamponade cases) were performed using the Student’s t-test. For categorical outcomes, the Chi-square test was used to compare proportions. A p-value of < 0.05 was considered statistically significant. Result: Intrauterine condom balloon tamponade (CBT) effectively managed atonic postpartum hemorrhage in 50 participants, achieving an 84% cessation of bleeding within 30 minutes. The average saline volume used was 500 mL, with a notable 16% of cases requiring additional surgical interventions, primarily hysterectomy. Blood transfusion was necessary for 68% of participants, with higher transfusion needs in cases of failed CBT. Maternal complications were minimal, with 8% experiencing postpartum fever and 4% developing uterine infections. The mean hospital stay was 5.0 days, with 40% staying longer than 5 days, reflecting the need for ongoing ..........

Effectiveness of the Intrauterine Balloon Tamponade Compared With an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device for Postpartum Hemorrhage

OBJECTIVE: To compare intrauterine balloon tamponade and vacuum-induced hemorrhage-control devices in a multicenter hospital system using a standardized three-stage postpartum hemorrhage response algorithm. METHODS: As part of a quality improvement project, data were prospectively collected through ongoing detailed hemorrhage case audits from 65 facilities from August 2022 to February 2024. Postpartum hemorrhage-control devices are recommended for stage 2 or 3 of the postpartum hemorrhage algorithm. The primary outcomes were 1) quantitative blood loss after device placement, 2) rate of packed red blood cell (RBC) transfusion, 3) use of 3 units of packed RBCs or more, and 4) device failure. RESULTS: During the 17-month observation period, there were 123,292 deliveries, and postpartum hemorrhage occurred in 5,931 (4.8%). Postpartum hemorrhage-control devices were used in 11.2% of cases (666 total, intrauterine balloon tamponade n=300, and vacuum-induced hemorrhage control n=366). For intrauterine balloon tamponade and vacuum-induced hemorrhage-control devices, quantitative blood loss (median and interquartile range) after device placement was similar at 194 (67–440) mL and 240 (113–528) mL (P=.40), respectively, as was the rate of any packed RBC transfusion (59.7% vs 50.0%, P=.08), transfusion of 3 packed RBC units or more (27.0% vs 24.9%, P=.53), and device failure (7.7% vs 8.5%, P=.70). Placement of either device at a quantitative blood loss between 1,000 and 1,499 mL compared with 1,500 mL or more resulted in significantly lower rates of packed RBC transfusion (39.1% vs 70.3%, P<.001), transfusion of 3 or more packed RBC units (13.7 vs 38.1%, P<.001), and device failure (3.4% vs 12.9%, P<.001). CONCLUSION: Transfusion and blood loss after device placement were similar with both hemorrhage-control devices. Earlier hemorrhage-control device placement reduced device failure and the need for transfusion.

Comprehensive Literature Review of the use of The Bakri Balloon for Managing Postpartum Hemorrhage

Postpartum hemorrhage (PPH) remains a significant cause of maternal mortality and morbidity worldwide. It is defined as excessive bleeding, typically more than 500 ml of blood loss within the first 24 hours after childbirth. The Bakri Balloon technique has emerged as a promising solution for managing PPH, offering a minimally invasive approach to achieving hemostasis and preventing the need for more invasive surgical procedures. Aims: The aim of this paper review is to provide an overview of the effectiveness of intrauterine balloon tamponade in managing PPH. Methods: We conducted this paper review by selecting articles, retrospective cohort studies and reviews from clinical trials from PubMed. Results: Numerous studies have shown high success rates of treating PPH using The Bakri Balloon intrauterine tamponade. Conclusions: The Bakri Balloon intrauterine tamponade is an effective method in the management of primary postpartum hemorrhage.

The SYNAPPH Study: Uterine Synechiae Prevalence After a Postpartum Hemorrhage, a Pilot Study

Study ObjectiveTo prospectively assess the prevalence of intrauterine synechia following medically treated postpartum hemorrhage (PPH) and to evaluate the association between synechiae formation and PPH management techniques. DesignA prospective observational cohort study. SettingAngers University Hospital. ParticipantsA total of 83 women presenting with medically treated PPH from January to December 2021 were included in the study. InterventionDiagnostic hysteroscopy was performed twelve weeks postpartum to assess for the presence of uterine synechiae. Detailed data on PPH management techniques were collected for analysis. Measurements and Main ResultsThe majority of participants were primiparous and had undergone vaginal delivery. Only 7% required intrauterine balloon tamponade (IUBT), and 4% underwent uterine artery embolization. Uterine synechiae were identified in 20 women during diagnostic hysteroscopy, yielding a prevalence of 24% at 12 weeks postpartum; all classified as type I according to the ESGE classification system. IUBT was used in 15% of women with synechiae compared to 5% in the nonsynechiae group, although this difference was not statistically significant (OR 3.52, 95% CI 0.65–19.10, p = .123). Multivariate analysis identified second manual uterine examination (OR 5.00, 95% CI 1.50–16.66, p = .009) and bimanual uterine massage (OR 3.50, 95% CI 1.12–10.09, p = .020) as independent risk factors for synechiae formation. ConclusionThis is the first study to evaluate the risk of intrauterine synechiae following medically treated PPH. Mild uterine synechiae were observed in one in four women in the cohort. The need for a second manual uterine examination and bimanual uterine massage were significantly associated with the development of synechiae. Further research is warranted to explore the long-term clinical consequences, including fertility outcomes, and to determine the potential role of diagnostic hysteroscopy in postpartum follow-up after PPH. SummationThe study prospectively investigates the prevalence of uterine synechiae following nonsurgical postpartum hemorrhage, revealing a 24% occurrence, with second manual uterine examination and bimanual massage identified as independent risk factors.

Efficacy of Early Intrauterine Balloon Tamponade for Immediate Postpartum Hemorrhage After Vaginal Delivery: A Randomized Clinical Trial

Efficacy of Early Intrauterine Balloon Tamponade for Immediate Postpartum Hemorrhage After Vaginal Delivery: A Randomized Clinical Trial

Innovative hemostasis technique for cesarean section in placenta previa: A retrospective study.

To evaluate hemostatic efficacy, complications, and subsequent pregnancy outcomes in women with placenta previa who underwent combined vertical compression sutures in the lower uterine segment and intrauterine balloon tamponade (Hot-Dog method) to achieve hemostasis after cesarean section. We retrospectively reviewed data for 117 women with singleton pregnancy diagnosed with placenta previa who underwent cesarean section between 29 and 38 weeks' gestation. Treatments were as follows: (1) conventional-intravenous oxytocin administration after placental detachment and suturing of bleeding points at the detachment site as needed (conventional group) (n = 47). (2) Intrauterine balloon tamponade alone (balloon group) (n = 41). (3) Vertical compression sutures + intrauterine balloon tamponade (Hot-Dog group) (n = 29). The placenta accreta spectrum prevalence was significantly higher in the balloon and Hot-Dog groups versus the conventional group. The prevalence of anteriorly located placenta was significantly higher in the Hot-Dog versus balloon groups. Intraoperative and total blood loss were significantly higher in the Hot-Dog versus conventional groups. Postoperative blood loss was significantly lower in the Hot-Dog versus balloon groups. Fewer additional procedures for managing postoperative hemorrhage were required in the Hot-Dog versus conventional and balloon groups. The number of subsequent pregnancies in the conventional, balloon, and Hot-Dog groups was 11 (23.4%), 8 (19.5%), and 4 (13.8%), respectively; all resulted in live births at term without serious obstetric complications. The Hot-Dog method is a straightforward and safe hemostasis technique for placenta previa that preserves fertility and controls severe bleeding.

A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation.

Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, in 2017, the mortality ratio was 462 out of every 100 000 live births, over 10 times higher than for high-resource settings. There are different treatments available for post-partum haemorrhage. The intrauterine balloon tamponade is a medical device that proved to be a simple and cost-effective approach. Currently, there are several balloon tamponades available, with different design and working principles. However, all these devices were designed for high-resource settings, presenting several aspects that could be inappropriate for many lower-income countries. This paper presents the results of a preclinical study aiming at informing the design, prototyping and validation of a 3D-printed intrauterine balloon tamponade concept, contributing towards the United Nation's Sustainable Development Goal 3: Good health and Well-being. Frugal engineering concepts and contextualised design techniques were applied throughout, to define the design requirements and specifications. The performance of the final prototype was validated against the requirements of the UK National Health System (NHS) technical guidelines and relevant literature, measuring the water leak and pressure drop over time, both open air and in a approximate uterus model. The resulting prototype is made up of six components, some of which are easy to retrieve, namely a water bottle, a silicone tube and an ordinary condom, while others can be manufactured locally using 3D printers, namely a modified bottle cap, a flow stopper and a valve for holding the condom in place. Validation testing bore promising results with no water or pressure leak open air, and minimal leaks in the approximate uterus model. This demonstrates that the 3D printed condom-based intrauterine balloon tamponade is performing well against the requirements and, when compared to the state of the art, it could be a more appropriate and more resilient solution to low-resource settings, as it bypasses the challenges in the supply of consumables and presents a greener option based on circular economy.

Interpretable machine learning predicts postpartum hemorrhage with severe maternal morbidity in a lower-risk laboring obstetric population

BackgroundEarly identification of patients at increased risk for postpartum hemorrhage (PPH) associated with severe maternal morbidity (SMM) is critical for preparation and preventative intervention. However, prediction is challenging in patients without obvious risk factors for postpartum hemorrhage with severe maternal morbidity. Current tools for hemorrhage risk assessment use lists of risk factors rather than predictive models. ObjectiveTo develop, validate (internally and externally), and compare a machine learning model for predicting PPH associated with SMM against a standard hemorrhage risk assessment tool in a lower risk laboring obstetric population. Study DesignThis retrospective cross-sectional study included clinical data from singleton, term births (>=37 weeks’ gestation) at 19 US hospitals (2016–2021) using data from 58,023 births at 11 hospitals to train a generalized additive model (GAM) and 27,743 births at 8 held-out hospitals to externally validate the model. The outcome of interest was PPH with severe maternal morbidity (blood transfusion, hysterectomy, vascular embolization, intrauterine balloon tamponade, uterine artery ligation suture, uterine compression suture, or admission to intensive care). Cesarean birth without a trial of vaginal birth and patients with a history of cesarean were excluded. We compared the model performance to that of the California Maternal Quality Care Collaborative (CMQCC) Obstetric Hemorrhage Risk Factor Assessment Screen. ResultsThe GAM predicted PPH with an area under the receiver-operating characteristic curve (AUROC) of 0.67 (95% CI 0.64–0.68) on external validation, significantly outperforming the CMQCC risk screen AUROC of 0.52 (95% CI 0.50–0.53). Additionally, the GAM had better sensitivity of 36.9% (95% CI 33.01–41.02) than the CMQCC screen sensitivity of 20.30% (95% CI 17.40–22.52) at the CMQCC screen positive rate of 16.8%. The GAM identified in-vitro fertilization as a risk factor (adjusted OR 1.5; 95% CI 1.2–1.8) and nulliparous births as the highest PPH risk factor (adjusted OR 1.5; 95% CI 1.4–1.6). ConclusionOur model identified almost twice as many cases of PPH as the CMQCC rules-based approach for the same screen positive rate and identified in-vitro fertilization and first-time births as risk factors for PPH. Adopting predictive models over traditional screens can enhance PPH prediction.

Comparison of Efficacy and Safety of Intrauterine Balloon Tamponade Versus Uterovaginal Packing in Females Presenting with Postpartum Hemorrhage after Normal Vaginal Delivery

To compare the efficacy and safety of intrauterine balloon tamponade with uterovaginal roll gauze packing in patients presenting with primary postpartum hemorrhage after normal vaginal delivery. This randomized controlled trial, conducted at Department of Obstetrics and Gynecology, Lady Willingdon Hospital, Lahore, from December 2015 to November 2016. Two hundred and twelve patients presenting with primary postpartum hemorrhage who did not respond to medical treatment following normal vaginal delivery were included. They were randomly divided in two groups. The first group underwent balloon tamponade using condom and second group underwent intrauterine packing using roll gauze. Both interventions were removed after 24 hours. All females were kept under observation with antibiotic coverage in ward to prevent infection. If bleeding was stopped within 15 minutes and the patient remained hemodynamically stable, then efficacy was labeled and if no complications occur while applying or removing, safety was labeled. Mean age group of women using balloon tamponade and intrauterine packing was used was 28.25±4.672 and 28.30±4.613 years. The mean gestational age of patients using balloon tamponade and intrauterine packing was 38.57±1.36 and 38.63±0.62 years. Mean blood loss in patients using balloon tamponade and intrauterine packing was 600.28±25.338 and 699.21±70.176 ml. Efficacy of intrauterine packing was 94 (88.7%) and balloon tamponade was 104 (98.1%). Safety of intrauterine packing was 83 (78.3%) and that of balloon tamponade was 97 (91.5%). Thus, treatment of balloon tamponade was more effective and safer than intrauterine packing in female presenting with postpartum hemorrhage after normal vaginal delivery.

Peut-on prévenir l’échec du ballon de tamponnement intra-utérin selon la voie d’accouchement ?

ObjectiveThe intrauterine balloon tamponade (IUBT) is one of the major tool to manage the postpartum hemorrhage (PPH). Previous studies identified factors predicting IUBT failure regardless the mode of delivery. Our aim was to determine if IUBT predictive failure can be determined regarding the mode of delivery. Materials and methodsThis was a retrospective cohort study among women who had IUBT secondary to severe PPH after vaginal or cesarean delivery from 2012 until 2021 at Lille (France). We compared 2 groups: success or failure of the IUBT, which was defined as the need of additional invasive procedures (uterine embolization or surgical procedure). ResultsWe included 238 women, 83 who underwent cesarean and 155 vaginal delivery. The overall success of the IUBT was 78% (80% for vaginal delivery and 75% for cesarean delivery). In the vaginal delivery group with failed IUBT, coagulopathies were significantly more frequent (84.2 vs. 33.3% P=<0.001) with higher estimated blood loss at the use of the IUBT (1865.8 vs. 1580.8mL, P=0.015) compared with the vaginal delivery group with success of IUBT. In the cesarean delivery group, none factor was significant between the two groups. ConclusionIt is possible to identify predictors of IUBT failure in case of vaginal delivery. In contrast, in case of cesarean delivery, there is no apparent predictive facto. It could be interesting to validate our findings in a multicentric study.

Uterine Balloon Tamponade in Management of Postpartum Hemorrhage

Aim. To evaluate the efficacy and safety of uterine balloon tamponade for the management of postpartum haemorrhage.Materials and Methods. We have screened the Cochrane Library and PubMed for the following keywords: “intrauterine balloon tamponade”, “controlled balloon tamponade”, “controlled balloon tamponade” AND “postpartum bleeding/haemorrhage” during 5 years (2018-2023). In total, we have identified 358 publications including 3 meta-analyses, 6 systematic reviews, and 13 randomized controlled trials. After checking titles and abstracts to remove duplicates, we selected 38 sources which met the selection criteria.Results. Postpartum haemorrhage remains the leading cause of maternal mortality in both developing and developed countries. In most cases, postpartum haemorrhage occurs due to atony and is controlled by administration of uterotonics. However, if uncurbed, postpartum haemorrhage requires blood transfusion and surgery. Currently, uterine balloon tamponade is considered as one of the most efficient and safe technologies for controlling postpartum haemorrhage and preventing hysterectomy, yet a number of studies have reported negative results. Several investigations showed an advantage of double-balloon tamponade as it provides an additional benefit of vascular compression of the lower uterine segment. Generally, uterine balloon tamponade is an efficient intervention which allows to avoid additional surgeries (uterine artery embolization or hysterectomy) in 87.3 – 100.0% of cases with a relatively low complication rate (&lt; 6.7% – 9.4%).Conclusion. The effectiveness of uterine balloon tamponade and the risk of complications are probably determined by the type of device, the learning curve effect, and the regularity and quality of training of medical personnel. Further in-depth multicenter studies in this direction are required.

Timely use of Bakri intrauterine balloon tamponade contributes to the effectiveness in controlling severe postpartum hemorrhage.

The aim of the present study was to explore the effectiveness of Bakri intrauterine balloon tamponade (IUBT) in treating severe postpartum hemorrhage (SPPH). A cohort of 198 women with SPPH using IUBT were retrospectively selected. The baseline and maternal outcome characteristics were examined. The results demonstrated that women with SPPH had a high proportion of placenta accrete (53.0%). Bakri IUBT demonstrated a global effectiveness of 84.5% in SPPH treatment, accounting for 82.9% in women with placenta accrete. Compared with women with Bakri failure, women who experienced Bakri success had reduced rates of less use of pre-/post-IUBT intervention, blood transfusion, lower genital tract trauma, estimated blood loss (EBL), and a longer indwelling duration (P<0.05). Logistic regression revealed that the pre-IUBT intervention (OR=3.910; 95% CI: 1.684-9.079; P=0.002) was positively associated with hemostasis success, while lower genital tract trauma was negatively associated with Bakri success (OR=0.091; 95% CI: 0.009-0.894; P=0.040). Moreover, women diagnosed with placenta accrete underwent a greater number of transabdominal placed Bakri IUBT and pre-IUBT interventions than those without placenta accrete (P<0.05). No significant differences were observed in Bakri success, total EBL, pre-/post-IUBT EBL, infused volume of IUBT, IUBT indwelling duration, even the rate of hemostasis, lower genital tract trauma, blood transfusion, post-IUBT intervention, and puerperal fever between women with and without placenta accrete (P>0.05). In conclusion, placenta accrete may be the leading cause of SPPH. Bakri IUBT is an effective and safe measure for SPPH. Pre-IUBT intervention may be predictive of Bakri's success. The timely use of IUBT during labor may mitigate the impact of risk factors identified on PPH.

Efficacy of Bakri Intrauterine Balloon in Managing Postpartum Hemorrhage: A Comparative Analysis of Vaginal and Cesarean Deliveries with Placenta Accreta Spectrum Disorders.

BACKGROUND The incidence of placenta accreta spectrum disorder (PAS) has been increasing in past decades, and women with PAS are a high-risk maternal population. This study aimed to explore the performance of Bakri intrauterine balloon tamponade (IUBT) in the treatment of postpartum hemorrhage (PPH), among those with and without PAS. MATERIAL AND METHODS The outcomes of 198 women who underwent treatment for PPH using IUBT were retrospectively analyzed. The demographics and maternal outcomes were analyzed for vaginal and cesarean births, with PAS and without PAS. RESULTS Compared to women with vaginal births (n=130), women who underwent cesarean births (n=68) showed a higher proportion of age ≥35 years (χ²=6.85, P=0.013), multiple births (χ²=13.60, P<0.001), preeclampsia (χ²=9.81, P=0.002), use of transabdominal IUBT (χ²=84.12, P<0.001) and pre-IUBT interventions (χ²=41.61, P<0.001), but had less infused volume of physiological saline (t=6.41, P<0.001). Women with PAS (n=105) showed a higher rate of pre-IUBT intervention (χ²=4.96, P=0.029) and transabdominal IUBT placement (χ²=9.37, P=0.002) than non-PAS women (n=93). The 36 women with PAS (n=36) showed a higher rate of preeclampsia (χ²=4.80, P=0.029), pre-IUBT intervention (χ²=5.90, P=0.015), and transabdominal IUBT placement (χ²=14.94, P<0.001) and a shorter duration from delivery to Bakri insertion (χ²=3.31, P=0.002), than non-PAS women (n=32). CONCLUSIONS PAS was a major cause of PPH at 198 vaginal and cesarean births. An accurate and timely pre-IUBT intervention and Bakri IUBT placement was critical for controlling PPH in cesarean births, especially in women with PAS.

Intrauterine Postpartum Hemorrhage-Control Devices.

Postpartum hemorrhage , defined as a cumulative blood loss of 1,000 mL or more or blood loss associated with signs or symptoms of hypovolemia regardless of the route of delivery, is the leading cause of preventable maternal death worldwide. The United States has one of the highest maternal mortality rates among developed countries, with about 14% of all maternal deaths associated with postpartum hemorrhage. Although postpartum hemorrhage has multiple causes, the most common is uterine atony-when the uterus fails to adequately contract after childbirth-accounting for 80% of all postpartum hemorrhages. When postpartum hemorrhage occurs despite preventive measures, therapeutic measures are used. Intrauterine hemorrhage-control devices are often the second-line therapy when medical management is unsuccessful. Despite its widespread use in current obstetric practice, the mechanism of intrauterine balloon tamponade, such as the Bakri balloon, is counterintuitive to the physiologic uterine contraction that occurs after delivery to control bleeding, and data on its effectiveness are mixed. Vacuum-induced hemorrhage control, such as with the Jada System, cleared by the U.S. Food and Drug Administration in 2020, is a novel modality for control of postpartum bleeding. It mimics postpartum physiology by applying low-level intrauterine negative pressure to facilitate uterine compressive forces, thereby constricting blood vessels to achieve hemostasis. Preliminary data from four studies are promising but are limited by a lack of control groups, selection bias, or modest sample sizes. The results of ongoing and planned randomized controlled trials will clarify the role of the Jada System for reducing morbidity from postpartum hemorrhage.

Investigation of the usefulness of intrauterine balloon tamponade after manual placental removal

Investigation of the usefulness of intrauterine balloon tamponade after manual placental removal

Intrauterine Tamponade Balloon for Management of Severe Postpartum Haemorrhage: Does Early Insertion Change the Outcome? A Retrospective Study on Blood Loss.

To evaluate the role of the timing of IUTB insertion and to assess the correlation between the time of insertion and outcome. A retrospective study in two tertiary care centres, including patients transferred for severe PPH management. A total of 81 patients were included: 52 patients with IUTB inserted before 15 min (group 1) and 29 patients with IUTB inserted after 15 min (group 2). The mean volume of blood loss in the group of patients with IUTB inserted before 15 min was significantly lower than in group of patients with IUTB set after 15 min. An IUTB could be inserted simultaneously with a uterotonic agent, within 15 min and not after 15 min as suggested by local guidelines, but further prospective studies are required to confirm this.

Efficacy of Balloon Tamponade in Postpartum Hemorrhage

Aim: An estimated loss of more than 500 mL of blood after vaginal delivery and more than 1000 mL of blood following caesarean delivery from the birth canal within 24 hours is considered primary postpartum haemorrhage (PPH). Rightfully termed the "obstetrician's nightmare," primary postpartum haemorrhage remains a major contributor to maternal mortality and morbidity in underdeveloped countries like Pakistan, where it accounts for 21-31% of maternal deaths. As a result, investigating PPH management strategies is vital. Objectives: To determine the efficacy of intrauterine balloon tamponade in the management of post-partum hemorrhage Study Design: Descriptive study Study Setting: Department of Obstetrics and Gynecology, Sheikh Zayed Medical from 21st May 2021 till 20th November 2021. Methods: Total 126 women aged 18-35 years, parity 1-6 and 31-41 weeks of gestation, who develop atonic post-partum hemorrhage not responding to uterotonics following normal vaginal delivery or caesarean section were enrolled using non-probability consecutive sampling technique. Women having postpartum hemorrhage were treated with balloon tamponade to stop bleeding. Efficacy was noted after 06 hours of procedure. Data was entered and analyzed using SPSS 25. Results: In this study total 126 patients were enrolled with mean age of 25.6±5.3 years. Mean gestational age was 38.2±3.2 weeks. Mean blood loss was 1032.1±379.6 ml. Mean parity was4.1±1.3. Most of patients had middle education i.e. 33.3%. Majority of patients belonged to middle socioeconomic status i.e. 47.6%. There were 41.3% patients who were booked and 2 had regular antenatal visits. Vaginal delivery was done in 55.6% patients. Balloon tamponade was effective in 81% patients. Practical Implication: Since balloon tamponade is a relatively new procedure, there is little information about its efficacy compared to the more traditional method of uterovaginal packing in Pakistan. Conclusion: Balloon tamponade is effective in stopping postpartum hemorrhage. The success rate (81%) of balloon tamponade in preventing PPH is high. It's convenient for use in situations with a higher risk of PPH. Keywords: Postpartum Hemorrhage, Balloon Tamponade, Delivery, Efficacy, Blood Loss, Management

Antibiotic Recommendations After Postpartum Uterine Exploration or Instrumentation.

Multiple postpartum scenarios require uterine exploration or instrumentation. These may introduce bacteria into the uterus, increasing the risk of endometritis. Data on the use of antibiotics in these scenarios is limited, resulting in few guidelines and divergent care. To describe postpartum scenarios requiring uterine exploration and/or instrumentation, review data on antibiotic prophylaxis, and delineate antibiotic recommendations for each scenario. Original articles were obtained from literature search in PubMed, MEDLINE, and OVID; pertinent articles were reviewed. These recommendations are based on published evidence and professional society guidelines. Antibiotic prophylaxis following manual placenta removal should include 1-time combination of ampicillin 2 g intravenously (IV) or cefazolin 1 g IV, plus metronidazole 500 mg IV. Antibiotic prophylaxis before postpartum dilation and curettage, manual vacuum aspiration, and intrauterine balloon tamponade should include 1-time combination of ampicillin 2 g IV plus metronidazole 500 mg IV. If the patient in any of the above scenarios has received group B Streptococcus prophylaxis, then only metronidazole is recommended. Further randomized clinical trials are needed to optimize these regimens. Uterine exploration or instrumentation increases the risk of postpartum endometritis and requires antibiotic prophylaxis. For manual placenta removal, we recommend 1-time combination of ampicillin 2 g IV or cefazolin 1 g IV, plus metronidazole 500 mg IV. For dilation and curettage, manual vacuum aspiration, and intrauterine balloon tamponade, we recommend 1-time combination of ampicillin 2 g IV plus metronidazole 500 mg IV. For patients who already received antibiotic prophylaxis for group B Streptococcus, we recommend 1-time dose of metronidazole 500 mg IV. Providers can utilize our guidelines to prevent postpartum endometritis in these scenarios requiring postpartum uterine exploration and/or instrumentation.

Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial

Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79-1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P=.06). The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures.